Medical technology refers to medical devices used for medical purposes. Medical technology is used for the prevention of illnesses as well as for diagnosis, treatment, monitoring, imaging or compensation for harm caused by illness or injury, together with rehabilitation.
The manufacture of medical devices is regulated by regulation MDR EU 2017/745. In addition, our work is framed by the certified ISO 13485 quality system, complemented by several individual standards for materials, dimensions and surface treatment that are used in manufacturing, for instance.
The ISO 13485 certificate covers processes related to the design and production of medical devices. With the help of the quality system, we ensure that the safety requirements of the legislation are fulfilled, and that we meet customer requirements at all stages of the product life cycle.
We maintain technical documentation on the medical devices we manufacture, including the description and purpose of the device, its markings and operating instructions, and product specifications. In addition, the documentation includes manufacturing, packaging, storage, handling, distribution, measurement and monitoring procedures.
Part of our equipment base is specially designed for the manufacture of instruments.
Modern methods of treatment impose special requirements on surgical equipment; as endoscopic surgeries become more common, the structures of the instruments will have to be as thin and durable as possible.
Often, a particular instrument is used only in operations involving a specific implant. Our experts have experience in a wide range of clinical materials, so we understand how implants made of biodegradable materials or ceramics, for example, behave. This is one of our strengths in designing and manufacturing implant-related instruments.
We have a cleanroom in our use where we carry out activities that meet strict purity criteria, such as the washing and packaging of surgical implants.
The reliability, quality, accuracy and speed of our work are based on the versatile professionalism and educational background of our staff. In addition to engineers, our staff includes experts in medicine, chemistry and biomaterials.
Mectalent's ISO 13485 certified service portfolio covers the following areas:
Our services include full documentation and traceability of the design and production history of medical devices.
Read reference stories
GE Healthcare is the world's leading medical technology company, with products, solutions and services that help healthcare professionals diagnose, treat and monitor patients. One of GE Healthcare's product groups is mammography equipment.
Mectalent manufactures components for the SenoGrapheTM Pristina device, which is used to perform breast cancer screenings and examinations. In addition to manufacturing parts, we take care of material purchases, coatings and the laser marking of components, as well as packaging and manufacturing documentation.
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